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Ketamine for MS Fatigue

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ketamine
Sponsored by
Alta Bates Summit Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS related Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Female and Male patients with any form of CDMS ages 18-65 inclusive Report fatigue which is interfering with QOL Able and willing to sign informed consent Stable on DMT for at least 3 months prior to baseline visit Not experiencing an MS relapse within 90 days prior to baseline visit. Must agree to practice an acceptable method of contraception Experiencing significant fatigue due to MS (MFIS of ≥10) Exclusion Criteria: Allergy to Ketamine Taking medications which may interact with ketamine Change in DMT within 3 months prior to baseline visit MS relapse within 90 days of the baseline visit Confirmed diagnosis of untreated Sleep Apnea Confirmed diagnosis of periodic limb movement disorder Serious infection in the 30 days prior to baseline visit. Patients with significant comorbid conditions: Untreated hypertension (SBP>160, DBP>100 at baseline) Liver disease Significant renal disease History of cardiac arrhythmia Any comorbidities which at the opinion of the investigators post undue risk Current alcohol or drug abuse Participation in another interventional clinical trial in the past 3 months. Pregnant or lactating Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Sites / Locations

  • Alta Bates Summit Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine (active treatment)

Saline (placebo treatment)

Arm Description

dose of 0.5 mg/kg intravenously over 40 minutes on day 1

Placebo (saline solution) over 40 minutes on day 1

Outcomes

Primary Outcome Measures

Improve Fatigue Scores
a statistically significant change in the level of fatigue score as measured by the MS fatigue scales between baseline and day 28 post study drug infusion

Secondary Outcome Measures

Improve Quality of Life
A statistically significant change in the patient's quality of life as measured by FILMS between baseline and day 28

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Alta Bates Summit Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06064162
Brief Title
Ketamine for MS Fatigue
Official Title
A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED FATIGUE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alta Bates Summit Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. We propose a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.
Detailed Description
The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group. After their first infusion cycle, they will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS related Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine (active treatment)
Arm Type
Active Comparator
Arm Description
dose of 0.5 mg/kg intravenously over 40 minutes on day 1
Arm Title
Saline (placebo treatment)
Arm Type
Placebo Comparator
Arm Description
Placebo (saline solution) over 40 minutes on day 1
Intervention Type
Drug
Intervention Name(s)
ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
60mg (.5mg/kg over 40 minutes intravenously)
Primary Outcome Measure Information:
Title
Improve Fatigue Scores
Description
a statistically significant change in the level of fatigue score as measured by the MS fatigue scales between baseline and day 28 post study drug infusion
Time Frame
28 days post study drug infusion
Secondary Outcome Measure Information:
Title
Improve Quality of Life
Description
A statistically significant change in the patient's quality of life as measured by FILMS between baseline and day 28
Time Frame
Between baseline and day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female and Male patients with any form of CDMS ages 18-65 inclusive Report fatigue which is interfering with QOL Able and willing to sign informed consent Stable on DMT for at least 3 months prior to baseline visit Not experiencing an MS relapse within 90 days prior to baseline visit. Must agree to practice an acceptable method of contraception Experiencing significant fatigue due to MS (MFIS of ≥10) Exclusion Criteria: Allergy to Ketamine Taking medications which may interact with ketamine Change in DMT within 3 months prior to baseline visit MS relapse within 90 days of the baseline visit Confirmed diagnosis of untreated Sleep Apnea Confirmed diagnosis of periodic limb movement disorder Serious infection in the 30 days prior to baseline visit. Patients with significant comorbid conditions: Untreated hypertension (SBP>160, DBP>100 at baseline) Liver disease Significant renal disease History of cardiac arrhythmia Any comorbidities which at the opinion of the investigators post undue risk Current alcohol or drug abuse Participation in another interventional clinical trial in the past 3 months. Pregnant or lactating Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepak Soneji, MD
Phone
510.204.8140
Email
Deepak.Soneji@sutterhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Cooper, MD
Phone
510.204.8140
Email
Joanna.Cooper@sutterhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Soneji, MD
Organizational Affiliation
Sutter East Bay Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Han, RN
Phone
510-204-1757
Email
Janet.Han@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Lilly Murray, RN
Phone
510-204-1608
Email
Lilly.Murray@sutterhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32633662
Citation
Fitzgerald KC, Morris B, Soroosh A, Balshi A, Maher D, Kaplin A, Nourbakhsh B. Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue. Mult Scler. 2021 May;27(6):942-953. doi: 10.1177/1352458520936226. Epub 2020 Jul 7.
Results Reference
result
PubMed Identifier
30312839
Citation
Saligan LN, Farmer C, Ballard ED, Kadriu B, Zarate CA Jr. Disentangling the association of depression on the anti-fatigue effects of ketamine. J Affect Disord. 2019 Feb 1;244:42-45. doi: 10.1016/j.jad.2018.10.089. Epub 2018 Oct 6.
Results Reference
result
PubMed Identifier
22935407
Citation
Induruwa I, Constantinescu CS, Gran B. Fatigue in multiple sclerosis - a brief review. J Neurol Sci. 2012 Dec 15;323(1-2):9-15. doi: 10.1016/j.jns.2012.08.007. Epub 2012 Aug 27.
Results Reference
result
PubMed Identifier
17409388
Citation
Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.
Results Reference
result
PubMed Identifier
15824337
Citation
Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.
Results Reference
result
PubMed Identifier
24963407
Citation
Asano M, Finlayson ML. Meta-analysis of three different types of fatigue management interventions for people with multiple sclerosis: exercise, education, and medication. Mult Scler Int. 2014;2014:798285. doi: 10.1155/2014/798285. Epub 2014 May 14.
Results Reference
result
PubMed Identifier
33242419
Citation
Nourbakhsh B, Revirajan N, Morris B, Cordano C, Creasman J, Manguinao M, Krysko K, Rutatangwa A, Auvray C, Aljarallah S, Jin C, Mowry E, McCulloch C, Waubant E. Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. Lancet Neurol. 2021 Jan;20(1):38-48. doi: 10.1016/S1474-4422(20)30354-9. Epub 2020 Nov 23.
Results Reference
result
PubMed Identifier
29464379
Citation
Broicher SD, Filli L, Geisseler O, Germann N, Zorner B, Brugger P, Linnebank M. Positive effects of fampridine on cognition, fatigue and depression in patients with multiple sclerosis over 2 years. J Neurol. 2018 May;265(5):1016-1025. doi: 10.1007/s00415-018-8796-9. Epub 2018 Feb 20.
Results Reference
result
PubMed Identifier
31741743
Citation
Meca-Lallana V, Branas-Pampillon M, Higueras Y, Candeliere-Merlicco A, Aladro-Benito Y, Rodriguez-De la Fuente O, Salas-Alonso E, Maurino J, Ballesteros J. Assessing fatigue in multiple sclerosis: Psychometric properties of the five-item Modified Fatigue Impact Scale (MFIS-5). Mult Scler J Exp Transl Clin. 2019 Nov 9;5(4):2055217319887987. doi: 10.1177/2055217319887987. eCollection 2019 Oct-Dec.
Results Reference
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PubMed Identifier
19737850
Citation
Wesson JM, Cooper JA, Jehle LS, Lockhart SN, Draney K, Barber J. The functional index for living with multiple sclerosis: development and validation of a new quality of life questionnaire. Mult Scler. 2009 Oct;15(10):1239-49. doi: 10.1177/1352458509107019. Epub 2009 Sep 8.
Results Reference
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PubMed Identifier
26774513
Citation
Beard C, Hsu KJ, Rifkin LS, Busch AB, Bjorgvinsson T. Validation of the PHQ-9 in a psychiatric sample. J Affect Disord. 2016 Mar 15;193:267-73. doi: 10.1016/j.jad.2015.12.075. Epub 2015 Dec 31.
Results Reference
result
Links:
URL
https://www.nationalmssociety.org/
Description
National Multiple Sclerosis Society

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Ketamine for MS Fatigue

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